Betamethasone and Salicylic Acid Ointments

Betamethasone and Salicylic Acid Ointments

PURPOSE: 

This Standard Operating Procedure is written to describe the formulae, manufacturing procedure, specifications, packing details of dosage form.

SCOPE:

This procedure is performed and is applied during the manufacturing of dosage form.

RESPONSIBILITY / ACCOUNTABILITY:

It is the responsibility of  Manufacturing Chemist to follow and adhere to this SOP. The Production Pharmacist, QC/QA Manager are accountable for the strict adherence to the master formula.

COPY ISSUED TO:

  1. Master Copy : Manager Quality Assurance
  2. Copy No. 1 : Production Pharmacist
  3. Copy No. 2 : Manager Quality Control
  4. Copy No. 3: Ointment Section
PRODUCT NAME: Betamethasone and Salicylic Acid Ointments BATCH SIZE:  200 KG
PRODUCT REFERENCE CODE:  UNIT SIZE:  20 g
GENERIC NAME: N.A. PACK SIZE:  24 ´ 12 ´ 20g
DOSAGE FORM: OINTMENT STRENGTH: N.A.
DEPARTMENT:  OINTMENT DEPARTMENT EXPIRY DATE: AFTER 24 MONTHS     FROM THE DATE OF MANUFACTURING

  COMPOSITION: 

Betamethasone Dipropionate U. S. P. 0.64 mg
Salicylic Acid I. P 30 mg

EQUIPMENTS TO BE USED: 

SR. NO. NAME OF EQUIPMENT ASSEMBLING

AS PER SOP NO.

CLEANING

AS PER SOP NO.

1 Wax Vessel    
2 Water Vessel    
3 Mixing Vessel    
4 Storage Container-I (500 Kg)    
5 Semiautomatic Aluminium Tube Filling & Crimping Machine    

 RAW MATERIALS: – 

S.NO. INGREDIENTS STD Theoretical Quantity Req. Overages % Total Quantity Used
1. BECLOMETHASONE DI PROPIONATE U.S.P. 128.000 4.68 133.990 GMS
2 CM – 1000 I.P. 2.000   2.000 KGS
3 CETOCETYL ALCOHOL I.P. 8.627   8.627 KGS
4 LIQUID PARAFFIN LIGHT I.P. 26.000   26.000 KGS
5 METHYL PARABEN (PLAIN) I.P. 0.200   0.200 KGS
6 PEG – 4000 I.P. 51.240   51.240 KGS
7 PEG – 400 I.P. 90.000   90.000 KGS
8 PROPYL PARABEN (PLAIN) I.P. 0.400   0.400 KGS
9 SLICYLIC ACID I.P. 6.000 5.00 6.300 KG
10 WHITE PETROLEUM JELLY I.P. 16.000   16.000 KG

 Packing Material Details 

S.NO. NAME OF THE MATERIAL THEORETICAL QUANTITY REQ. FOR

RECORD

TOTAL QUANTITY USED
1. ADHESIVE TAPE ROLL BROWN 1.000   1.000 NOS
2. CELLO TAPE 2.000   2.000 NOS
3 TUBES 10000.000   10000.000 NOS
4 UNIT CARTON 10000.000 3.000 10003.000 NOS
5 OUTER CARTON 833.000 2.000 835.000 NOS
6 CORRUGATED BOXES  T – 10 35.000   35.000 NOS

  MANUFACTURING SPECIFICATION:

  1. Average fill of each Tube is 20 grams.
  2. Weight variation limit allowed in each filled Tube is + 200 mg.
  3. Melt the waxes at the maintained temperature 700
  4. Colloid till uniform particle size is achieved.
  5. The temperature of primary area should not exceed 30˚C 

        Yield:

  • Theoretical Yield is 10000 Tubes.
  • Expected Practical Yield is 10000 + 2% Tube. 

   Packing Details:

  1. Transfer the cream from storage tank to Semiautomatic Aluminium Tube Filling & Crimping Machine and start filling and then Crimping of the tubes as per its SOP .
  2. Pack the filled tubes in unit carton.
  3. Pack such 12 tubes in each outer carton.
  4. Seal the outer carton with cello tape.
  5. Pack the 24 outer cartons in specified corrugated box  to give a pack size of 24 x 12 x 20g Tubes.
  6. Seal the each corrugated box with adhesive tape and label it properly by affixing the specified label.

  MANUFACTURING PROCESS: 

  1. Melt 2.0 kg of Ceto Macrogol- 1000, 8.627 kg of Cetocetyl Alcohol, 24.0kg of liquid Paraffin light  24 kg of PEG-4000 and 16 kg of White Petroleum Jelly at the temperature 65˚ C in a Steam Heat Wax Melting Vessel by operating it as per its SOP .
  2. Filter and transfer the melted base through Stainless Steel Sieve no. 100 to the mixing vessel and start the machine as per its SOP .
  3. Dissolve 6.300kg of Salicylic Acid in 80.0 kgs PEG-400 and transfer it to the mixing vessel containing wax at 45 C
  4. Heat 10.0 kg of PEG-400 to 60 C and dissolve 0.200 kg of Methyl Paraben and 0.400kg of Propyl paraben to it. Transfer it to the mixing vessel.
  5. Allow the mixing of all the added ingredients in the same mixing vessel till the cream solidifies to room temperature.
  6. Cool the cream to the room temperature by running the water in the jacket of Planetary Mixer.
  7. Triturate and dissolve 133.99 g of Betamethasone Di-Propionate in 2 kg of Liquid Paraffin Light in mortar–pestle and add to the bulk batch at the temperature 35˚
  8. Mix the whole batch for 2 hours while running the water in the jacket.
  9. Send the sample to Quality Control Department for bulk testing.
  10. After approval from Quality Control Department, transfer the cream to the storage tank.

      IN-PROCESS CONTROLS: 

The following in-process controls should be maintained during the processing:

  1. Check Raw materials used for manufacturing purpose are all approved materials and have ‘Released’ labels fixed on it.
  2. All weighed Raw materials should be counter-checked by Assistant Manufacturing Chemist. If any discrepancy is noticed, it should be immediately brought to the notice of Production Pharmacist and QC/QA Manager.
  3. Physical characteristics of Raw material like colour, odour, and consistency are checked before compounding.
  4. The total weight of bulk ointment / cream should be checked in the presence of Assistant Manufacturing Chemist and record the same in Batch Manufacturing Record.
  5. pH of the bulk should be checked and it should be with in specified limits.
  6. Bulk sample should be sent for analysis to Quality Control Department before starting the filling and sealing stage.
  7. While the tube filling operation is on, the Assistant Manufacturing Chemist should check weight of net filled quantity per tube at the interval of 30 minutes by checking the tare weight of empty tube and gross weight of the filled tube. Record for the same should be kept in Batch Manufacturing Record.
  8. The ‘fill weight’ of ointment or cream per tube should not be less than the labelled amount.

         Limit for Weight Variation:  Weight claimed on the carton + 200 mg

  1. Assistant Manufacturing Chemist will also ensure that the crimping of the filled Aluminium tubes, sealing of plastic tubes is appropriate and embossing of batch number and manufacturing date is conspicuous. Also the quality of embossing will be controlled by adjusting pressure exerted by the jaws, so that pinholes are not developed on the embossed letters / numbers.
  2. The inner and outer cartons should be checked thoroughly for proper batch coding.
  3.  Manufacturing Chemist and Production Pharmacist should randomly check that the correct no. of inner cartons are being packed in each outer cartons and also the correct number of outer cartons in each shipper is exactly the same as that shown in proof.
  4. Intimation should be sent to Quality Control Department for finished product sampling and testing.
  5. After the completion of filling and packaging, the coded cartons should be accounted for and rejected printed material should be destroyed in the presence of QC/QA Manager. Maintain the destruction of the same in the Batch Manufacturing Record.
  6. It will be ensure that filling or packaging equipment has been properly cleaned.
  7. Filling or packaging of next product should be commenced only after getting the ‘Line Clearance’ of the previous product, from the IPQA.

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